Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultrat...
FDA Recall #D-0469-2022 — Class II — January 24, 2022
Product Description
Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
Reason for Recall
cGMP deviations
Recalling Firm
Ultra Seal Corporation — New Paltz, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
297,050 packets
Distribution
Nationwide within the United States
Code Information
Lot #: AK9602, Exp. Date 05/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.